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When FDA Might Approve A Coronavirus Vaccine

ARI SHAPIRO, HOST:

The Trump administration launched Operation Warp Speed in May. The goal is to deliver initial doses of a safe and effective COVID-19 vaccine by this coming January. That would be a speed record for developing a vaccine. And some fear the administration might cut corners to meet that ambitious schedule as a way to gain a political advantage. Joining us to talk about this confluence of science and politics is NPR's Joe Palca.

Hi, Joe.

JOE PALCA, BYLINE: Hi, Ari.

SHAPIRO: The administration says it wants to cut through red tape to speed up the approval process. So how much red tape is there?

PALCA: Well, the job of approving a vaccine falls to the Food and Drug Administration. And, yes, there are - there is some red tape. But the whole reason the FDA exists is to protect the American people from unsafe and ineffective products. So at a minimum, FDA wants to see any vaccine tested in thousands of people and that any relative side effects will be found. And if the vaccine is - and they want to know if the vaccine is actually preventing disease. And the FDA doesn't - says the vaccine doesn't have to prevent 100% of disease to get a green light, just 50% would be sufficient.

SHAPIRO: How soon can those tests be completed?

PALCA: Well, large studies are underway now involving tens of thousands of people. But you can only speed up these trials so much. For example, some of the vaccines require two doses a month apart, and you can't shorten a month into two weeks. It doesn't work. So now there's a separate outside group called the Data Safety and Monitoring Board keeping an eye on things. And they see the data from the study as it comes in.

Paul Offit is a vaccine developer at Children's Hospital of Philadelphia. He's expressed concerns that the Trump administration could try to say a vaccine is successful before the data show that. But he trusts this outside board will make sure there are no dangerous side effects from the vaccine.

PAUL OFFIT: If they see strong, clear, statistically robust evidence that a vaccine is effective and they feel the trial could even be stopped early for that reason - great. I'm all for it.

SHAPIRO: So let's imagine they do see this evidence. What happens then?

PALCA: Well, normally, that would allow the manufacturer to come to the FDA and say, look, we have a working vaccine. And at that point, the FDA could agree and issue something called an emergency use authorization, or EUA. But things get a little murky here because the FDA doesn't have to show the data it's using to make its decision. But in this case, the FDA commissioner, Stephen Hahn, has promised that the agency would share the data. This is what he wrote in an editorial in the medical journal JAMA - transparent discussion at FDA's Vaccines and Related Biological Products Advisory Committee will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy.

SHAPIRO: OK. So if there is that transparency and everybody gets to see the evidence, does that mean everyone will be convinced?

PALCA: No (laughter). No because there's always differences of opinion. It's rarely clear that something is absolutely working or absolutely not working. But Offit says the worst thing would be to authorize the use of an ineffective vaccine to try to stop the pandemic.

OFFIT: Don't screw this up. The vaccine is our best way out of it at this point. And to shake the American confidence further with either an unsafe or ineffective vaccine would be, I think, a disaster.

SHAPIRO: The last word there from Dr. Paul Offit brought to us by NPR's Joe Palca.

Thanks, Joe.

PALCA: You're welcome, Ari. Transcript provided by NPR, Copyright NPR.